Trial Outcomes & Findings for Study Evaluating Pantoprazole in Children With GERD (NCT NCT00141817)
NCT ID: NCT00141817
Last Updated: 2011-12-28
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
41 participants
Primary outcome timeframe
Predose (0 hour), and 0.5, 1, 2, 4, 6, 12 hours postdose
Results posted on
2011-12-28
Participant Flow
Participant milestones
| Measure |
Pantoprazole 0.6 mg/kg Spheroids
Pantoprazole 0.6 mg/kg Spheroids for Participants Aged \<6 years
|
Pantoprazole 1.2 mg/kg Spheroids
Pantoprazole 1.2 mg/kg Spheroids for Participants Aged \<6 years
|
Pantoprazole 0.6 mg/kg Tablets
Pantoprazole 0.6 mg/kg Tablets for Participants Aged \>=6 years
|
Pantoprazole 1.2 mg/kg Tablets
Pantoprazole 1.2 mg/kg Tablets for Participants Aged \>=6 years
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
7
|
10
|
11
|
13
|
|
Overall Study
COMPLETED
|
6
|
10
|
10
|
13
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
1
|
0
|
Reasons for withdrawal
| Measure |
Pantoprazole 0.6 mg/kg Spheroids
Pantoprazole 0.6 mg/kg Spheroids for Participants Aged \<6 years
|
Pantoprazole 1.2 mg/kg Spheroids
Pantoprazole 1.2 mg/kg Spheroids for Participants Aged \<6 years
|
Pantoprazole 0.6 mg/kg Tablets
Pantoprazole 0.6 mg/kg Tablets for Participants Aged \>=6 years
|
Pantoprazole 1.2 mg/kg Tablets
Pantoprazole 1.2 mg/kg Tablets for Participants Aged \>=6 years
|
|---|---|---|---|---|
|
Overall Study
Protocol Violation
|
0
|
0
|
1
|
0
|
|
Overall Study
Parent request
|
1
|
0
|
0
|
0
|
Baseline Characteristics
Study Evaluating Pantoprazole in Children With GERD
Baseline characteristics by cohort
| Measure |
Pantoprazole 0.6 mg/kg Spheroids
n=7 Participants
Pantoprazole 0.6 mg/kg Spheroids for Participants Aged \<6 years
|
Pantoprazole 1.2 mg/kg Spheroids
n=10 Participants
Pantoprazole 1.2 mg/kg Spheroids for Participants Aged \<6 years
|
Pantoprazole 0.6 mg/kg Tablets
n=11 Participants
Pantoprazole 0.6 mg/kg Tablets for Participants Aged \>=6 years
|
Pantoprazole 1.2 mg/kg Tablets
n=13 Participants
Pantoprazole 1.2 mg/kg Tablets for Participants Aged \>=6 years
|
Total
n=41 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age Continuous
|
3.86 years
STANDARD_DEVIATION 1.46 • n=5 Participants
|
2.80 years
STANDARD_DEVIATION 1.55 • n=7 Participants
|
8.55 years
STANDARD_DEVIATION 1.97 • n=5 Participants
|
8.77 years
STANDARD_DEVIATION 1.09 • n=4 Participants
|
6.41 years
STANDARD_DEVIATION 3.11 • n=21 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
16 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
25 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Predose (0 hour), and 0.5, 1, 2, 4, 6, 12 hours postdosePopulation: Single-Dose Valid-for-Evaluation Population: Randomized participants who took 1 dose of pantoprazole and had at least 4 single-dose blood samples for pharmacokinetic (PK) analyses.
Outcome measures
| Measure |
Pantoprazole 0.6 mg/kg Spheroids
n=3 Participants
Pantoprazole 0.6 mg/kg Spheroids for Participants Aged \<6 years
|
Pantoprazole 1.2 mg/kg Spheroids
n=7 Participants
Pantoprazole 1.2 mg/kg Spheroids for Participants Aged \<6 years
|
Pantoprazole 0.6 mg/kg Tablets
n=10 Participants
Pantoprazole 0.6 mg/kg Tablets for Participants Aged \>=6 years
|
Pantoprazole 1.2 mg/kg Tablets
n=13 Participants
Pantoprazole 1.2 mg/kg Tablets for Participants Aged \>=6 years
|
|---|---|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax)
|
136 nanogram per milliliter (ng/mL)
Standard Deviation 127
|
798 nanogram per milliliter (ng/mL)
Standard Deviation 729
|
1643 nanogram per milliliter (ng/mL)
Standard Deviation 1229
|
2067 nanogram per milliliter (ng/mL)
Standard Deviation 1320
|
PRIMARY outcome
Timeframe: Predose (0 hour), and 0.5, 1, 2, 4, 6, 12 hours postdosePopulation: Single-Dose Valid-for-Evaluation Population. Participants analyzed=number of participants with available data.
Outcome measures
| Measure |
Pantoprazole 0.6 mg/kg Spheroids
n=3 Participants
Pantoprazole 0.6 mg/kg Spheroids for Participants Aged \<6 years
|
Pantoprazole 1.2 mg/kg Spheroids
n=7 Participants
Pantoprazole 1.2 mg/kg Spheroids for Participants Aged \<6 years
|
Pantoprazole 0.6 mg/kg Tablets
n=10 Participants
Pantoprazole 0.6 mg/kg Tablets for Participants Aged \>=6 years
|
Pantoprazole 1.2 mg/kg Tablets
n=12 Participants
Pantoprazole 1.2 mg/kg Tablets for Participants Aged \>=6 years
|
|---|---|---|---|---|
|
Time to Reach Maximum Observed Plasma Concentration (Tmax)
|
1.45 hours
Standard Deviation 0.69
|
2.71 hours
Standard Deviation 1.25
|
2.08 hours
Standard Deviation 0.75
|
2.03 hours
Standard Deviation 0.74
|
PRIMARY outcome
Timeframe: Predose (0 hour), and 0.5, 1, 2, 4, 6, 12 hours postdosePopulation: Single-Dose Valid-for-Evaluation Population.
AUC (0-t)= Area under the plasma concentration versus time curve from time zero (predose) to time of last quantifiable concentration (0-t).
Outcome measures
| Measure |
Pantoprazole 0.6 mg/kg Spheroids
n=3 Participants
Pantoprazole 0.6 mg/kg Spheroids for Participants Aged \<6 years
|
Pantoprazole 1.2 mg/kg Spheroids
n=7 Participants
Pantoprazole 1.2 mg/kg Spheroids for Participants Aged \<6 years
|
Pantoprazole 0.6 mg/kg Tablets
n=10 Participants
Pantoprazole 0.6 mg/kg Tablets for Participants Aged \>=6 years
|
Pantoprazole 1.2 mg/kg Tablets
n=13 Participants
Pantoprazole 1.2 mg/kg Tablets for Participants Aged \>=6 years
|
|---|---|---|---|---|
|
Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)]
|
208.96 nanogram hour per milliliter (ng*h/mL)
Standard Deviation 197.54
|
2273.96 nanogram hour per milliliter (ng*h/mL)
Standard Deviation 1885.68
|
2448.61 nanogram hour per milliliter (ng*h/mL)
Standard Deviation 2007.21
|
3190.96 nanogram hour per milliliter (ng*h/mL)
Standard Deviation 2137.91
|
PRIMARY outcome
Timeframe: Predose (0 hour), and 0.5, 1, 2, 4, 6, 12 hours postdosePopulation: Single-Dose Valid-for-Evaluation Population. Participants analyzed=number of participants with available data.
AUC (0 - ∞)= Area under the plasma concentration versus time curve (AUC) from time zero (predose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).
Outcome measures
| Measure |
Pantoprazole 0.6 mg/kg Spheroids
n=3 Participants
Pantoprazole 0.6 mg/kg Spheroids for Participants Aged \<6 years
|
Pantoprazole 1.2 mg/kg Spheroids
n=7 Participants
Pantoprazole 1.2 mg/kg Spheroids for Participants Aged \<6 years
|
Pantoprazole 0.6 mg/kg Tablets
n=10 Participants
Pantoprazole 0.6 mg/kg Tablets for Participants Aged \>=6 years
|
Pantoprazole 1.2 mg/kg Tablets
n=11 Participants
Pantoprazole 1.2 mg/kg Tablets for Participants Aged \>=6 years
|
|---|---|---|---|---|
|
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]
|
293.29 ng*h/mL
Standard Deviation 146.41
|
2448.08 ng*h/mL
Standard Deviation 2170.48
|
2497.13 ng*h/mL
Standard Deviation 2099.64
|
3782.49 ng*h/mL
Standard Deviation 1837.42
|
PRIMARY outcome
Timeframe: Predose (0 hour), and 0.5, 1, 2, 4, 6, 12 hours postdosePopulation: Single-Dose Valid-for-Evaluation Population. Participants analyzed=number of participants with available data.
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
Outcome measures
| Measure |
Pantoprazole 0.6 mg/kg Spheroids
n=3 Participants
Pantoprazole 0.6 mg/kg Spheroids for Participants Aged \<6 years
|
Pantoprazole 1.2 mg/kg Spheroids
n=7 Participants
Pantoprazole 1.2 mg/kg Spheroids for Participants Aged \<6 years
|
Pantoprazole 0.6 mg/kg Tablets
n=10 Participants
Pantoprazole 0.6 mg/kg Tablets for Participants Aged \>=6 years
|
Pantoprazole 1.2 mg/kg Tablets
n=11 Participants
Pantoprazole 1.2 mg/kg Tablets for Participants Aged \>=6 years
|
|---|---|---|---|---|
|
Plasma Decay Half-Life (t1/2)
|
5.34 hours
Standard Deviation 7.39
|
1.68 hours
Standard Deviation 0.64
|
0.77 hours
Standard Deviation 0.22
|
0.70 hours
Standard Deviation 0.16
|
PRIMARY outcome
Timeframe: Predose (0 hour), and 0.5, 1, 2, 4, 6, 12 hours postdosePopulation: Single-Dose Valid-for-Evaluation Population. Participants analyzed=number of participants with available data.
Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population pharmacokinetic (PK) modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.
Outcome measures
| Measure |
Pantoprazole 0.6 mg/kg Spheroids
n=3 Participants
Pantoprazole 0.6 mg/kg Spheroids for Participants Aged \<6 years
|
Pantoprazole 1.2 mg/kg Spheroids
n=7 Participants
Pantoprazole 1.2 mg/kg Spheroids for Participants Aged \<6 years
|
Pantoprazole 0.6 mg/kg Tablets
n=10 Participants
Pantoprazole 0.6 mg/kg Tablets for Participants Aged \>=6 years
|
Pantoprazole 1.2 mg/kg Tablets
n=11 Participants
Pantoprazole 1.2 mg/kg Tablets for Participants Aged \>=6 years
|
|---|---|---|---|---|
|
Apparent Oral Clearance (CL/F)
|
2.08 liter per hour per kilogram (L/h/kg)
Standard Deviation 1.27
|
1.28 liter per hour per kilogram (L/h/kg)
Standard Deviation 1.16
|
0.41 liter per hour per kilogram (L/h/kg)
Standard Deviation 0.30
|
0.40 liter per hour per kilogram (L/h/kg)
Standard Deviation 0.22
|
PRIMARY outcome
Timeframe: Predose (0 hour), and 0.5, 1, 2, 4, 6, 12 hours postdosePopulation: Single-Dose Valid-for-Evaluation Population. Participants analyzed=number of participants with available data.
Vz/F was calculated as the ratio of clearance (CL) to terminal disposition rate constant (λz).
Outcome measures
| Measure |
Pantoprazole 0.6 mg/kg Spheroids
n=3 Participants
Pantoprazole 0.6 mg/kg Spheroids for Participants Aged \<6 years
|
Pantoprazole 1.2 mg/kg Spheroids
n=7 Participants
Pantoprazole 1.2 mg/kg Spheroids for Participants Aged \<6 years
|
Pantoprazole 0.6 mg/kg Tablets
n=10 Participants
Pantoprazole 0.6 mg/kg Tablets for Participants Aged \>=6 years
|
Pantoprazole 1.2 mg/kg Tablets
n=11 Participants
Pantoprazole 1.2 mg/kg Tablets for Participants Aged \>=6 years
|
|---|---|---|---|---|
|
Terminal-Phase Volume of Distribution (Vz/F)
|
12.22 liter per kilogram (L/kg)
Standard Deviation 14.68
|
2.89 liter per kilogram (L/kg)
Standard Deviation 2.92
|
0.43 liter per kilogram (L/kg)
Standard Deviation 0.30
|
0.40 liter per kilogram (L/kg)
Standard Deviation 0.27
|
PRIMARY outcome
Timeframe: Hours 2 and 4 on Day 7Population: Multiple-Dose Valid-for-Evaluation Population: Randomized participants who had concentration evaluations of pantoprazole either at 2 hours or at 4 hours after single dose and after at least 5 consecutive doses. n=participants who had data available at that specific time point.
Outcome measures
| Measure |
Pantoprazole 0.6 mg/kg Spheroids
n=6 Participants
Pantoprazole 0.6 mg/kg Spheroids for Participants Aged \<6 years
|
Pantoprazole 1.2 mg/kg Spheroids
n=8 Participants
Pantoprazole 1.2 mg/kg Spheroids for Participants Aged \<6 years
|
Pantoprazole 0.6 mg/kg Tablets
n=10 Participants
Pantoprazole 0.6 mg/kg Tablets for Participants Aged \>=6 years
|
Pantoprazole 1.2 mg/kg Tablets
n=13 Participants
Pantoprazole 1.2 mg/kg Tablets for Participants Aged \>=6 years
|
|---|---|---|---|---|
|
Plasma Concentrations After Multiple Doses
Hour 2 on Day 7 (n=5, 8, 10, 13)
|
212.30 ng/mL
Standard Deviation 222.08
|
486.49 ng/mL
Standard Deviation 605.22
|
592.32 ng/mL
Standard Deviation 914.57
|
2337.89 ng/mL
Standard Deviation 1817.78
|
|
Plasma Concentrations After Multiple Doses
Hour 4 on Day 7 (n=6, 8, 10, 13)
|
503.25 ng/mL
Standard Deviation 1087.91
|
207.23 ng/mL
Standard Deviation 211.92
|
123.83 ng/mL
Standard Deviation 163.78
|
200.78 ng/mL
Standard Deviation 209.81
|
Adverse Events
Pantoprazole 0.6 mg/kg Spheroids
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Pantoprazole 1.2 mg/kg Spheroids
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Pantoprazole 0.6 mg/kg Tablets
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Pantoprazole 1.2 mg/kg Tablets
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Pantoprazole 0.6 mg/kg Spheroids
n=7 participants at risk
Pantoprazole 0.6 mg/kg Spheroids for Participants Aged \<6 years
|
Pantoprazole 1.2 mg/kg Spheroids
n=10 participants at risk
Pantoprazole 1.2 mg/kg Spheroids for Participants Aged \<6 years
|
Pantoprazole 0.6 mg/kg Tablets
n=11 participants at risk
Pantoprazole 0.6 mg/kg Tablets for Participants Aged \>=6 years
|
Pantoprazole 1.2 mg/kg Tablets
n=13 participants at risk
Pantoprazole 1.2 mg/kg Tablets for Participants Aged \>=6 years
|
|---|---|---|---|---|
|
General disorders
Abdominal pain
|
14.3%
1/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
10.0%
1/10
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
27.3%
3/11
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
7.7%
1/13
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Accidental injury
|
14.3%
1/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
10.0%
1/10
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
9.1%
1/11
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
7.7%
1/13
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Fever
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
10.0%
1/10
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
9.1%
1/11
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
7.7%
1/13
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Cardiac disorders
Hypotension
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
10.0%
1/10
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/11
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/13
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Diarrhea
|
14.3%
1/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
30.0%
3/10
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
9.1%
1/11
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/13
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
20.0%
2/10
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/11
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/13
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Vomiting
|
14.3%
1/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
30.0%
3/10
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/11
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/13
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Metabolism and nutrition disorders
Creatine phosphokinase increased
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
10.0%
1/10
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/11
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/13
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Metabolism and nutrition disorders
Thirst
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
10.0%
1/10
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/11
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/13
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Metabolism and nutrition disorders
Weight loss
|
14.3%
1/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/10
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/11
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/13
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Abnormal/changed behavior
|
14.3%
1/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/10
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/11
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/13
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Cough increased
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
20.0%
2/10
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/11
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/13
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Maculopapular rash
|
14.3%
1/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/10
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/11
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/13
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Ear and labyrinth disorders
Otitis media
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
10.0%
1/10
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
18.2%
2/11
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/13
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Renal and urinary disorders
Urinary tract infection
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
10.0%
1/10
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/11
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/13
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory infection
|
14.3%
1/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
10.0%
1/10
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
18.2%
2/11
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/13
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Headache
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/10
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
9.1%
1/11
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
15.4%
2/13
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Injection site hemorrhage
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/10
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/11
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
7.7%
1/13
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Injection site pain
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/10
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
9.1%
1/11
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/13
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Pain
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/10
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/11
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
7.7%
1/13
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Eructation
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/10
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/11
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
7.7%
1/13
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Gastroenteritis
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/10
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/11
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
7.7%
1/13
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Metabolism and nutrition disorders
Hyperlipemia
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/10
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/11
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
7.7%
1/13
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/10
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/11
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
7.7%
1/13
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/10
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/11
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
7.7%
1/13
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/10
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
9.1%
1/11
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/13
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/10
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
9.1%
1/11
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/13
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Contact dermatitis
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/10
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/11
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
7.7%
1/13
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Eye disorders
Eye disorder
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/10
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
9.1%
1/11
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/13
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER